Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.

Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.

Other Names:

Sustiva (efavirenz)

Viramune (nevirapine)

Experimental: 2

High dose nevirapine (400 mg in the morning, 200 mg in the evening) in combination with 2 nucleoside analogs

Drug: efavirenz or nevirapine

Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.

Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.

Other Names:

Sustiva (efavirenz)

Viramune (nevirapine)

Experimental: 4

High dose efavirenz (800 mg at bedtime) in combination with 2 nucleoside analogs

Drug: efavirenz or nevirapine

Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.

Other Names:

Sustiva (efavirenz)

Viramune (nevirapine)

Detailed Description:

This is an open label, randomized study with 4 arms: 1.) Standard dose and 2.) high dose nevirapine; and 3.) standard dose and 4.) high dose efavirenz. Subjects in all 4 arms will also receive 2 nucleoside analog drugs. Patients will have routine monitoring for the treatment of TB and HIV, as well as some additional blood samples to follow the virus in the blood and to determine the effect of the TB therapy on the amounts of anti-HIV drugs that are in the body.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

ARV naïve subjects

Documented HIV infection

Documented TB infection

Platelet count 40,000/mm3

Hemoglobin ≥8.0 g/dL

Absolute neutrophil count (ANC) >500/mm3

AST (SGOT), ALT (SGPT), and alkaline phosphatase <3 X ULN

Total bilirubin <2.5 x ULN

Calculated creatinine clearance ≥60 mL/min

For women of reproductive potential, negative urine pregnancy test

Exclusion Criteria:

Unable to provide informed consent.

History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.

Patients on hemodialysis.

Tuberculosis meningitis.

Women with CD4 > 250 and men with CD4 > 400 due to higher risk of hepatotoxicity related to use of NVP.

Positive serology for hepatitis C.

Evidence for active hepatitis B including positive serologies for HBsAg, HBeAg, or HBV-DNA. Note: If anti-HBs is positive, patient is eligible for study if liver enzymes are within the parameters indicated in the inclusion criteria

Women who are breast-feeding

Known allergy/sensitivity to study drug(s) or their formulations

Patients with other OIs or intercurrent illness that could affect their ability to take study drugs

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523458